Job Title: Clinical Research Lead
Hiring Manager: Head Scientific Communications
Location: Hyderabad, India
Travel Requirement: As per business needs
Job Type: Permanent, Full-time
Company: Sanofi
Department: Scientific Communications / Clinical Research
About the Team:
Sanofi Business Operations (SBO) is a strategic internal global hub in India supporting functions across Specialty Care, Vaccines, General Medicines, Consumer Healthcare, Contract Manufacturing, R&D, and Data & Digital. SBO enables delivery for global Medical, HEVA, and Commercial organizations.
Main Responsibilities:
Lead and manage clinical trial activities, ensuring compliance with regulatory and organizational requirements.
Contribute to strategic plans: Clinical Development Plan (CDP), Integrated Development Plan (IDP), Target Product Profile (TPP), and more.
Support clinical studies through medical training, feasibility assessment, data review, and scientific communication.
Provide medical responses to Health Authorities, Ethics Committees, and investigators.
Perform medical review of safety events, participate in Centralized Monitoring activities, and ensure data quality.
Develop clinical study documents: protocols, amendments, consent forms, investigator brochures, CSRs, Lay Summaries, and CTD sections.
Oversee processes such as code-breaking, IVRS setup, central reading input, and CAP approval.
Lead the development and functioning of Adjudication Committees, Steering Committees, and DMCs.
Collaborate with internal stakeholders: Biostatistics, Regulatory Affairs, Pharmacovigilance, CROs, Global Clinical Leads, and Medical Affairs.
Prepare medical presentations and participate in investigator meetings.
Manage and mentor clinical scientists and ensure effective cross-functional communication.
Required Experience:
Strong scientific and clinical expertise.
Demonstrated experience in clinical development, ideally with Phase 3 trials.
Proficient in protocol design, safety and efficacy data interpretation, and regulatory compliance.
Experience in scientific writing, publications, and stakeholder engagement.
Soft Skills:
Effective trainer and communicator in cross-functional and international environments.
Advanced leadership and negotiation skills.
Strong interpersonal, conflict resolution, and decision-making abilities.
Open-minded and adaptable to digital innovation.
Ability to work within a matrix model.
Technical Skills:
Expertise in Pulmonary, Allergy, Immunology, or equivalent drug development experience.
Deep knowledge of relevant literature, clinical landscape, and competitor data.
Capability to challenge norms with a risk-management mindset.
Resource negotiation and operational planning skills.
Education:
Medical Doctor (MD) degree required
Languages:
Fluent English (verbal and written)
Diversity & Inclusion:
Sanofi is an equal opportunity employer committed to building a diverse and inclusive workforce. Watch our ALL IN video and learn more about our actions at sanofi.com.
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